SODIUM FERRIC GLUCONATE COMPLEX- sodium ferric gluconate complex injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

SODIUM FERRIC GLUCONATE COMPLEX (UNII: CC9149U2QX) (FERRIC CATION - UNII:91O4LML611)

MAH:

Actavis Pharma, Inc.

INN:

SODIUM FERRIC GLUCONATE COMPLEX

composition:

FERRIC CATION 12.5 mg in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. - Known hypersensitivity to sodium ferric gluconate or any of its components. Pregnancy Category B There are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. Reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). The doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly need

leaflet_short:

How Supplied NDC 0591-0149-87       Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials.       Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use,       packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.

authorization_status:

Abbreviated New Drug Application

SPC

SODIUM FERRIC GLUCONATE COMPLEX- SODIUM FERRIC GLUCONATE COMPLEX
INJECTION
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SODIUM FERRIC GLUCONATE COMPLEX IN
SUCROSE INJECTION.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, FOR INTRAVENOUS
(IV) USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Sodium ferric gluconate complex in sucrose injection is an iron
replacement product for treatment of iron deficiency
anemia in adult patients and in pediatric patients age 6 years and
older with chronic kidney disease receiving hemodialysis
who are receiving supplemental epoetin therapy. (1)
DOSAGE AND ADMINISTRATION
Adult Patients -The recommended adult dosage is 10 mL (125 mg of
elemental iron) diluted in 100 mL of 0.9% sodium
chloride administered by intravenous infusion over 1 hour per dialysis
session or undiluted as a slow intravenous
injection (at a rate of up to 12.5 mg/min) per dialysis session. (2.1)
Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg
(1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride
and administered by intravenous infusion over 1
hour per dialysis session. (2.2)
Do not mix sodium ferric gluconate complex in sucrose injection with
other medications or add to parenteral nutrition
solutions for intravenous infusion.
Administer in 0.9% saline (2)
DOSAGE FORMS AND STRENGTHS
Sodium ferric gluconate complex in sucrose injection is supplied in a
single use vial containing 62.5 mg of elemental iron in
5 mL. (3)
CONTRAINDICATIONS
Known hypersensitivity to sodium ferric gluconate or any of its
inactive components. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Monitor patients for signs and symptoms of
hypersensitivity during and after sodium ferric
gluconate complex in sucrose injection administration for at least 30
minutes and until clinically stable f